MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-30 for PARADYM 2 PARADYM 2 VR 8252 manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[115667660]
The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
Patient Sequence No: 1, Text Type: N, H10
[115667661]
Reportedly, during an extra follow-up performed on (b)(6) 2018, 73 vf episodes and 1 inappropriate shock were observed due to noise oversensing. The right ventricular continuity is above 3000ohms and the right ventricular impedance value at 2931ohms. Alert on the ventricular lead impedance and on the rv shock continuity higher than 3000ohms were observed. On (b)(6) 2018, a reintervention occurred and part of the lead has been explanted (cut and isolated), the rest remained abandoned. The icd remains implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2018-00695 |
| MDR Report Key | 7731116 |
| Date Received | 2018-07-30 |
| Date of Report | 2018-07-30 |
| Date of Event | 2018-07-04 |
| Date Facility Aware | 2018-07-06 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 2014-08-21 |
| Date Added to Maude | 2018-07-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELODIE VINCENT |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R . |
| Manufacturer City | CLAMART 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92140 |
| Manufacturer Phone | 0146013665 |
| Manufacturer G1 | SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R . |
| Manufacturer City | CLAMART 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PARADYM 2 |
| Generic Name | SINGLE-CHAMBER IMPLANTABLE DEFIBRILLATOR |
| Product Code | LWO |
| Date Received | 2018-07-30 |
| Model Number | PARADYM 2 VR 8252 |
| Catalog Number | PARADYM 2 VR 8252 |
| Lot Number | 2846 |
| Device Expiration Date | 2015-09-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
| Manufacturer Address | PARC D'AFFAIRES NOVEOS 4 AVENUE R?AUMUR . CLAMART 92140 FR 92140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-30 |